Understanding genetic changes in metastatic pancreatic cancer
Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis
This study is trying to understand the genetic changes in pancreatic cancer by looking at tumor and blood samples from patients starting chemotherapy to see if these changes can help tailor better treatments for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | British Columbia Cancer Agency Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Calgary, Alberta and 3 other locations) |
| Trial ID | NCT02869802 on ClinicalTrials.gov |
What this trial studies
This observational study aims to better understand metastatic pancreatic ductal adenocarcinoma (PDAC) by analyzing genetic changes in tumor samples and blood from patients undergoing first-line chemotherapy. Researchers will collect fresh tumor biopsies and blood samples to perform comprehensive genomic analyses and assess how these genetic characteristics correlate with treatment responses. The study will include 190 patients and will focus on those receiving either FOLFIRINOX or gemcitabine and nab-paclitaxel regimens. The goal is to identify potential biomarkers that could guide personalized treatment strategies in the future.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a histological or radiological diagnosis of metastatic PDAC who are planned for first-line systemic therapy.
Not a fit: Patients who do not have metastatic PDAC or those who are not eligible for first-line systemic therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, personalized treatment options for patients with metastatic pancreatic cancer.
How similar studies have performed: Other studies have shown promise in using genomic analysis to tailor cancer treatments, indicating that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological and/or radiological diagnosis of metastatic PDAC. Patients without a histological diagnosis of PDAC must undergo confirmatory tumour biopsy prior to treatment start date. * Planned for first-line systemic therapy with FOLFIRINOX or GP, either in routine care or in combination with an investigational agent(s) within a clinical trial. * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate organ function * Life expectancy of \> 90 days as judged by the investigator * Ability to give informed consent * Measurable disease by RECIST 1.1 * Presence of a tumour lesion amenable to core needle biopsy as judged by a staff interventional radiologist. A minimum of 3 tumour cores must be safely obtainable under CT or US guidance. * Fit enough to safely undergo a tumour biopsy as judged by the investigator * Ability to lie supine for \> 60 minutes Patients in the archival cohort must also fulfil the following criteria: * Archival tumour sample available (either a previous tumour diagnostic biopsy or resection specimen) Exclusion Criteria: * Absence of distant or lymph node metastases. Patients with borderline resectable or locally advanced PDAC are not eligible. * Received prior systemic therapy (chemotherapy or any other anti-cancer agent) in the advanced setting. Patients who received adjuvant chemotherapy after surgical resection of early stage disease are eligible. * Currently receiving anti-cancer therapy (chemotherapy or any other anti-cancer agent) * Not fit for combination chemotherapy as judged by the investigator * Presence of brain metastases * Female patients with positive pregnancy test * Patients who are not safe to include in the study as judged by the investigator for any medical or non-medical reason * Unable to comply with study assessments and follow-up
Where this trial is running
Calgary, Alberta and 3 other locations
- Tom Baker Cancer Centre — Calgary, Alberta, Canada (Recruiting)
- Cross Cancer Institute — Edmonton, Alberta, Canada (Withdrawn)
- BC Cancer - Vancouver — Vancouver, British Columbia, Canada (Recruiting)
- The Ottawa Hospital — Ottawa, Ontario, Canada (Active_not_recruiting)
Study contacts
- Principal investigator: Daniel J Renouf, MD — BC Cancer
- Study coordinator: Daniel J Renouf, MD
- Email: drenouf@bccancer.bc.ca
- Phone: 800-663-3333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.